Nociceptive chronic low back pain Musculoskeletal Diseases
Conditions
Interventions
Randomization:
Participants will be randomized into treatment groups using RedCap software. A statistician outside of the research team will generate the randomization sequence and upload it on RedCap
Sponsors
Concordia University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Chronic non-specific LBP (>3 months) defined based on the NIH task force recommendations 2. Between 18 and 60 years of age 3. Speak English or French (to allow response to questionnaires and communication with therapist) 4. Present with predominant nociceptive chronic LBP, namely, score Category A for nociceptive drivers, Category 0 for nervous system dysfunction (absence of neurological involvement), Category 0 for comorbidity drivers (absence of comorbidity), and Category 0 for cognitive-emotional factors and Category 0 or A contextual for drivers on the Pain and Disability Drivers Management (PDDM).
Exclusion criteria
Exclusion criteria: 1. Previous spinal surgery or vertebral fractures 2. Radiculopathy 3. Other major lumbar spine structural abnormalities (e.g., spondylolysis, spondylolisthesis, or lumbar scoliosis >10°) 4. Health conditions that would prevent active participation in exercise (e.g. systemic inflammation) 5. Institutional contraindications for undergoing an MRI exam (e.g., pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of disability in relation to LBP measured using the Oswestry Low Back Pain Disability Index (ODI) score at baseline and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Multifidus muscle fatty infiltration (composition) measurements obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels, which will be measured automatically using convolutional neural networks (CNNs). Timepoints: Baseline, 16 weeks. 2. Multifidus cross-sectional area and cumulative 3D volume from magnetic resonance imaging (MRI) slices from L1 to L5 spinal levels (bilaterally) measured automatically using convolutional neural networks (CNNs). Timepoints: Baseline, 16 weeks. 3. Lumbar extensor muscle strength assessed using a MedX Lumbar Extension Machine. Timepoints: Baseline, 16 weeks. 4. Gluteal muscle strength assessed using a handheld dynamometer VALD DynaMo. Timepoints: Baseline, 16 weeks. 5. Hip range of motion in flexion and extension measured using a handheld dynamometer VALD DynaMo. Timepoints: Baseline, 16 weeks. 6. Pain and how it interferes with physical and mental function, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.0 score. Timepoints: Baseline, 16 weeks. 7. Pain measured using the visual numerical pain rating scale (NPR) and the “Manage My Pain” app. Timepoints: Baseline, 16 weeks. 8. Health-related quality of life measured using the 12-item Short Form Health Survey (SF-12). Timepoints: Baseline, 16 weeks. 9. Perceived recovery and satisfaction measured using the Satisfaction and Recovery Index (SRI). Timepoints: Baseline, 16 weeks. 10. Sleep quality. Participants will be sent a wrist-worn actigraph (AX3, Axivity) in order to further evaluate sleep disturbance. Participants will be asked to use the actigraph for 7 days at home for objective estimation of average sleep latency, wake after sleep onset, total sleep time and sleep efficiency, and asked to complete a sleep diary. Timepoints: Baseline, 16 weeks. 11. Physical activity measured using the International Physical Activity Questionnaire (IPAQ). Timepoints: Baseline, 16 weeks. 12. Qualitative inquiry. Potential participants w | — |
Countries
Canada
Contacts
Public ContactMaryse Fortin
Outcome results
None listed